A Study of Ixekizumab (LY2439821) in Chinese Participants With Moderate-to-Severe Plaque Psoriasis
A Multicenter Study With a Randomized, Double-Blind, Placebo-Controlled Induction Dosing Period Followed by a Randomized Maintenance Dosing Period to Evaluate the Efficacy and Safety of LY2439821 in Chinese Patients With Moderate-to-Severe Plaque Psoriasis
2 other identifiers
interventional
438
1 country
17
Brief Summary
The purpose of this study is to determine the efficacy and safety of the study drug ixekizumab in Chinese participants with moderate-to-severe plaque psoriasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2018
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 9, 2017
CompletedFirst Posted
Study publicly available on registry
December 6, 2017
CompletedStudy Start
First participant enrolled
April 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2020
CompletedResults Posted
Study results publicly available
June 25, 2021
CompletedJune 25, 2021
June 1, 2021
2.1 years
November 9, 2017
June 3, 2021
June 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With a Static Physician Global Assessment (sPGA) Score of Clear (0) or Minimal (1) With at Least a 2 Point Improvement
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participants Ps were assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline.
Week 12
Percentage of Participants Achieving a ≥75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region \* area score \* weighing factor \[head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)\]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Week 12
Secondary Outcomes (14)
Percentage of Participants Achieving a Static Physician Global Assessment (sPGA) Score of Clear (0) (Remission)
Week 12
Percentage of Participants Achieving a ≥90% Improvement in Psoriasis Area and Severity Index (PASI 90)
Week 12
Percentage of Participants Achieving a 100% Improvement in Psoriasis Area and Severity Index (PASI 100)
Week 12
Percentage of Participants Achieving an Itch Numeric Rating Scale (NRS) ≥4 Point Reduction From Baseline for Participants Who Had Baseline Itch NRS ≥4
Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
Baseline, Week 12
- +9 more secondary outcomes
Study Arms (3)
Ixekizumab 80mg Q4W
EXPERIMENTALParticipants received starting dose of 160 milligrams (mg) Ixekizumab at week 0 followed by 80mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection during induction period.
Ixekizumab 80mg Q2W
EXPERIMENTALParticipants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab once every two weeks (Q2W) by subcutaneous injection during induction period.
Placebo
PLACEBO COMPARATORParticipants received placebo every two weeks (Q2W) by subcutaneous (SC)injection during induction period.
Interventions
Eligibility Criteria
You may qualify if:
- Present with chronic plaque Ps based on a confirmed diagnosis of chronic Ps vulgaris for at least 6 months prior to baseline.
- Have ≥10% BSA involvement at screening and baseline.
- Have both an sPGA score ≥3 and PASI score ≥12 at screening and baseline.
- Are candidates for phototherapy and/or systemic therapy.
You may not qualify if:
- Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic and/or guttate psoriasis) at screening or baseline.
- Drug-induced psoriasis.
- Ongoing use of prohibited treatments.
- Have previously completed or withdrawn from this study, or have previously exposed to ixekizumab or any other biologic drug directly targeting interleukin-17 (IL-17) (such as secukinumab) or the IL-17 receptor.
- Have concurrent or recent use of any biologic agent within washout periods or \<5 half-lives prior to baseline, whichever is longer.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Guangdong Province People's Hospital
Guangzhou, Guangdong, 510080, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
YanCheng First People's Hospital
Yancheng, Jiangsu, 224005, China
The Second Hospital of Jilin University
Changchun, Jilin, 130022, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Nanjing, 210029, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710004, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Second Affiliate Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, 310009, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, 310014, China
Beijing Chao Yang Hospital
Beijing, 100020, China
Peking University First Hospital
Beijing, 100034, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, 200025, China
Shanghai Dermatology Hospital
Shanghai, 200443, China
Related Publications (2)
Gao X, Pan W, Zheng M, Li F, Dong X, Lv D, Guo Z, Li J, Wang X, Geng S. Efficacy and Safety Analysis in Chinese Patients with Moderate-to-Severe Psoriasis from a Phase 3 Trial: Impact of Treatment Withdrawal and Retreatment of Ixekizumab. Adv Ther. 2025 Jan;42(1):334-347. doi: 10.1007/s12325-024-03030-5. Epub 2024 Nov 13.
PMID: 39535685DERIVEDLi X, Ding Y, Zhang C, Lu Y, Li F, Pan W, Guo S, Li J, Zhao B, Zheng J. Efficacy of Ixekizumab in Chinese Patients with Moderate-to-Severe Psoriasis and Special Body Area Involvement: Sub-analysis of a Randomized, Double-Blind, Multicenter Phase 3 Study. Adv Ther. 2025 Jan;42(1):146-163. doi: 10.1007/s12325-024-02976-w. Epub 2024 Sep 30.
PMID: 39347926DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 9, 2017
First Posted
December 6, 2017
Study Start
April 26, 2018
Primary Completion
June 4, 2020
Study Completion
June 4, 2020
Last Updated
June 25, 2021
Results First Posted
June 25, 2021
Record last verified: 2021-06-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.